UrolithiasisNCT03043612
Ureteral Stent Study
A study testing Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin and Cook Sof-Flex® Double Pigtail Ureteral Stent in people with Urolithiasis, run by Cook Group Incorporated at 1 site in Hong Kong.
Trial summary
The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin and Cook Sof-Flex® Double Pigtail Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jun 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral stenting is indicated
Who cannot join
- Patient is unwilling or unable to sign and date the informed consent
- Patient is unwilling to comply with the follow-up study schedule
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- Patient is currently taking anti-cholinergic or other anti-spasm medications
- Patient is currently taking sildenafil, tadalafil, or vardenafil
- Patient has a known sensitivity to alpha-blocker medications
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- Patient is currently undergoing chemotherapy or radiation therapy
- Patient has an active urinary tract infection
- Patient is in chronic renal failure, on hemodialysis, or on chronic peritoneal dialysis
- Patient requires bilateral shock wave lithotripsy, bilateral stents, or has bilateral symptomatic kidney stones
- Patient has had a ureteral stent within the past three months in either ureter
- Patient is unable to accurately detect or report bladder function or pain
- Patient has chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cook Ureteral Stent Study
The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.
- Conditions
- Urolithiasis
- Being tested
- Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin, Cook Sof-Flex® Double Pigtail Ureteral Stent
- Keywords
- Ureteroscopy for urolithiasis
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosinDevice
Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
Cook Sof-Flex® Double Pigtail Ureteral StentDevice
Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
| Study group | Role | What they receive |
|---|---|---|
| Ureteral Study Stent | Experimental | Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication Receives: Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin |
| Ureteral Control Stent | Active comparator | Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent Receives: Device: Cook Sof-Flex® Double Pigtail Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported body pain score
Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms
Measured: 7-days post stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start10 Jun 2015
- Primary completion16 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chi-Fai Ng, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043612
- Sponsor's protocol ID
- 13-15
- Status last verified
- Jun 2017
- First submitted
- 31 Jan 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cook Ureteral Stent Study
- ClinicalTrials.gov ID
- NCT03043612
- Acronym / sponsor ID
- 13-15
- Conditions
- Urolithiasis
- Keywords
- Ureteroscopy for urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ureteral Study Stent | Experimental | Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosinCommercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication |
| Ureteral Control Stent | Active comparator | Device: Cook Sof-Flex® Double Pigtail Ureteral StentCommercially available Cook Sof-Flex® Double Pigtail Ureteral Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral stenting is indicated
Key exclusion criteria (13 listed)
- Patient is unwilling or unable to sign and date the informed consent
- Patient is unwilling to comply with the follow-up study schedule
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- Patient is currently taking anti-cholinergic or other anti-spasm medications
- Patient is currently taking sildenafil, tadalafil, or vardenafil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosinPlacement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis | Device | Ureteral Study Stent |
| Cook Sof-Flex® Double Pigtail Ureteral StentPlacement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis | Device | Ureteral Control Stent |
Primary outcome
Patient-reported body pain score
Time frame: 7-days post stent placement
Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Fai Ng principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin and Cook Sof-Flex® Double Pigtail Ureteral Stent in people with Urolithiasis, run by Cook Group Incorporated at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported body pain score (time frame: 7-days post stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.